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Taking people in United StatesPhase 2

Evaluation of Uterine Fibroids by CEUS and SHAPE Pre and Post UAE

Key facts

Who runs it
Thomas Jefferson University
Where
Philadelphia, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
80 people, planned
Started
27 Jan 2025
Planned end
30 Sept 2026
Type of study
Interventional
Treatments tested
  • Perfluten
Record updated
10 April 2025

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Be a female diagnosed with endometrial cancer and scheduled for UAE
  • Be over the age of 18 years
  • If the subject is of child-bearing potential, must have a negative pregnancy test
  • Be conscious and able to comply with study procedures
  • Have read and signed the IRB approved consent form for participating in the study

Who cannot take part

  • Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours afterwards
  • Patients who have undergone surgery within 24 hours prior to the study sonographic examination
  • Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
  • Patients with recent cerebral hemorrhage
  • Patients with congenital heart defects
  • Patient with a known allergy to Definity
  • Females who are pregnant or nursing
  • Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
  • Patients on life support or in a critical care unit

Where in United States

  • Thomas Jefferson UniversityPhiladelphia, United StatesContact: Priscilla MachadoTaking people

About the trial

What the trial wants to find out

This study goals are to determine the patterns of uterine fibroid vascularity pre and post UAE using CEUS resulting in an alternative to gadolinium-enhanced MRI that is less expensive, has less contra-indications and side effects, is real time, and noninvasive helping physicians to evaluate the result of UAE procedures. Also, this study will evaluate uterine fibroid pressures using SHAPE, comparing the results with normal myometrium tissue in order to determine its characteristics and tissue differences, which we believe will lead to the development of a new biomarker for the diagnosis and treatment of uterine fibroids.

The group in the trial

  • Uterine fibroidsTreatment being tested

    Treatment: Perfluten

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Uterine Fibroids by Contrast Enhanced Ultrasound (CEUS) and Subharmonic- Aided Pressure Estimation (SHAPE) Pre and Post-Uterine Artery Embolization (UAE)
Record updated
10 April 2025